Massachusetts’ top court on Friday opened the door for consumers to sue Merck & Co Inc and other makers of brand-name drugs over injuries blamed not on their own medications but on generic versions of their treatments made by other companies.
The Massachusetts Supreme Judicial Court ruled that brand-name drugmakers can be sued for recklessness if they intentionally fail to update warning labels for their drugs that makers of cheaper, generic versions must adopt as well.
The case was closely watched within the industry, and Merck drew support from industry groups including the U.S. Chamber of Commerce. Merck in a statement said it was disappointed and stands by the drug at issue, Proscar.
The decision came in a lawsuit by Massachusetts resident Brian Rafferty, who said he suffered from side effects, including sexual dysfunction, after taking the generic version of Merck’s Proscar to treat an enlarged prostate beginning in 2010.
Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels.
As a result, Rafferty instead sued Merck, saying its Provacar label failed to warn that such side effects could continue after discontinuing use of the drug. A lower-court judge dismissed his negligence claims.
The top court reversed, allowing Rafferty to sue Merck for recklessness rather than negligence. This requires a higher standard of proof showing a drugmaker intentionally failed to update its warning label despite knowing the risks.
“Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product, but also the users of the generic product,” Chief Justice Ralph Gants wrote.
Shielding brand-name manufacturers from liability entirely would leave consumers with no chance to sue generic drug companies, whose products command about 90 percent of the market, Gants wrote for the 4-0 court.
The decision was the latest by a top state court to weigh whether brand-name drugmakers can be sued over injuries blamed on generic drugs. The California Supreme Court in December ruled brand-name manufacturers could be sued by generic drug users.
Emily Lee-Smith, Rafferty’s lawyer, said while she did not believe the heightened recklessness standard in Massachusetts was needed, “we think it’s a step in the right direction.”
The case is Rafferty v. Merck & Co Inc, Massachusetts Supreme Judicial Court, No. SJC-12347.
Reporting by Nate Raymond in Boston; Editing by David Gregorio